Description

Epn Impurity 1 CAS NO 32341-58-5 is a high-purity reference standard and analytical impurity used in pharmaceutical research and development. It serves as a critical marker for ensuring the quality, safety, and regulatory compliance of active pharmaceutical ingredients (APIs) and finished drug products. This compound is essential for analytical chemists, quality control laboratories, and R&D departments within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in Epn-based drug substances and products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods, such as HPLC and LC-MS.
• Stability Studies: Employed to monitor the formation of degradation products in drug formulations under various stress conditions.
• Quality Control & Assurance: Acts as a system suitability standard and a benchmark for ensuring batch-to-batch consistency and purity in manufacturing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Research Chemical: Utilized in academic and industrial research to study metabolic pathways, degradation mechanisms, and chemical synthesis routes.

Basic Information

Product Name	Epn Impurity 1
CAS No.	32341-58-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	EPN Impurity A; EPN Related Compound A; O-Ethyl O-4-nitrophenyl phenylphosphonothioate Impurity 1; Phosphonothioic acid, phenyl-, O-ethyl O-(4-nitrophenyl) ester impurity; 32341-58-5; EPN-Imp-1
EINECS	Contact for details

Quality Control

Our Epn Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and trace analysis is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material should be handled in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.